Needle suture package



NEEDLE SUTURE PACKAGE Filed Dec, 21, 196'? INVENTOR WILLIAM H. SHAVELEONARD D. KURTZ ATTORNEYS United States Patent O 3,487,917 NEEDLESUTURE PACKAGE William H. Shave, Roosevelt, and Leonard D. Kurtz,Woodmere, N.Y., assignors to Deknatel, Incorporated, Queens Village, NY.

Filed Dec. 21, 1967, Ser. No. 692,567 Int. Cl. A61l17/02;B65d /42, 33/16US. Cl. 206-633 Claims ABSTRACT OF THE DISCLOSURE A package for aneedled suture of surgical gut including a main section and a coverlayer having an end flap. When the package is assembled the end flap isfolded underneath the main section and the upper and lower edges of thepackage are crimped. The package material is multi-layered and includesan absorbent layer for retaining liquid adjacent the surgical gut and asealing layer of metallic foil.

FIELD OF THE INVENTION The present invention relates to surgicalpackages and more particularly to an improved surgical package providingconsiderable resistance to drying out of the surgical gut.

BACKGROUND OF THE INVENTION AND THE PRIOR ART In our co-pendingapplication Ser. No. 584,731, now US. Patent 3,363,751, granted Jan. 16,1968, there is disclosed an improved needle surgical package whereinfoldable side panels enclose or imprison, first, a surgical suturearranged in a linear zig-zag configuration and, secondly, the attachedsuture needle, in alternate layers formed by the panels. This packagingarrangement provides efficient and expeditious handling of the sutureand particularly provides for rapid and efficient removal of the suturefrom the package at the time of use. This avoids the necessity ofopening multiple packages and laying out many sutures prior to use.Normally surgical sutures are packaged in an inner and outer envelope.The inner envelope contains the tubing fluid which retains the suture ina moist, usable condition. However, under present practice it isnecessary for the surgical nurse to open a number of envelopes and layout a number of the surgical gut sutures on a towel sometime prior touse. Thus the gut is exposed and subject to drying out for a period oftime prior to actual use.

The package of US. Patent 3,147,861, invented by one of the co-inventorshere, may be referred to for an example of a prior arrangement used inpackaging sutures employing surgical gut.

BRIEF SUMMARY OF THE INVENTION The present invention provides a packagespecifically designed for sutures of surgical gut which enables thesurgical gut to be retained in a moist usable condition in the operatingroom and has ready removal features similar to those of the packagedisclosed in our prior application.

In accordance with one feature of the present invention the packageforms a sealed container for a tubing fluid such as a mixture of alcoholand water which serves to decrease the evaporation rate of the fluid andthereby increase the time of evaporation. In accordance with anotherfeature of the present invention the package material includes anabsorbent layer which serves as a reservoir for the tubing fluid andthereby increases the amount of time necessary for drying.

3,487,917. Patented Jan. 6, 1970 "ice In accordance with a presentlypreferred embodiment the suture is disposed on a base or central portionof a laminated sheet and the side panels are folded thereover with theneedle disposed between the two folded side panels as disclosed in ourprior application. One side panel has an end panel or flap formedthereon which is folded around the bottom surface of the base or centralpanel. The ends of the package are then crimped so that tubing fluidused in keeping the surgical gut moist is completely sealed within thepackage. By using a crimping operation to seal the package the packagemay be readily opened by a nurse at the time the surgical gut is to beused and the gut may be removed from the pack age in the same manner asdisclosed in our prior application. The package material preferablyincludes an inner layer of absorbent material which surrounds thesurgical gut and thus forms a reservoir for retaining the tubing fluid.

Thus a package is provided for surgical gut which eliminates the wastageand inefficiency attendant with the use of prior art packages. Thepackage is opened immediately before use so that there is no drying outof the gut. It is only necessary to open the exact number of suturepackages which are to be used so that there is no wastage. By utilizingan absorbent inner layer there is no danger of spillage of the fluidmaintaining the gut in a moist state when the package is opened as therewill be substantially no free fluid in the package under thesecircumstances. In this regard and in accordance with a further featureof the invention the surgical gut and/or the absorbent inner layer maybe pre-soaked to a condition of maximum absorption such thatevaporation.

and spilling is combatted.

BRIEF DESCRIPTION OF THE DRAWINGS Other features and advantages of thepresent invention will be apparent upon consideration of the followingdetailed description of a preferred embodiment of the invention takenwith the accompanying drawings wherein:

FIGURES l-4 illustrate various steps followed in forming a packagedsuture in accordance with the invention, FIGURE 3 being partially cutaway to show a portion of the suture needle;

FIGURE 5 illustrates a step in the removal of the suture from thepackage by a user; and

FIGURE 6 is an enlarged section view taken along line 6-6 of FIGURE 1showing the construction of the packaging material.

DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGURES 1-4, thesuture package of the present invention is formed from a rectangularsheet of material denoted 10 which is folded along a first longitudinalfold line 11 a second longitudinal fold line 12 and a third longitudinalfold line 13 to form a main section B, a first side panel A, a secondside panel C and an end panel D. A needle suture 20- having a first end22 and a needle end 21 is disposed on the meain section B of sheet 10between fold lines 11 and 12 starting from the first end 22 andcontinuing in a zig-zag manner such that each longitudinal linearportion of the suture 20 lies adjacent and parallel to the previous lineas shown in FIGURE 1. The zig-zag placement of the suture 20- extendacross the main section B and the end of the suture having needle 21attached extends beyond the edge of the main section as shown in FIGURE1.

Side panel A is folded about fold line 11 to cover and enclose orcapture the linear zig-zag arrangement of suture 20 as shown in FIGURE2. With panel A so folded, the end portion of suture 20 including needle21 is bent about 3 the lower edge of panel A as shown in FIGURE 2 sothat it lies above panel A.

In the next step, side panel C is folded about fold line 12 therebyenclosing needle 21 between panels A and C as shown in FIGURE 3. Panel Cis shown partially cut away to show a portion of the needle 21 with theremainder of the needle 21 being shown in dotted lines in FIGURE 3.

To complete the folding of the package, end panel D is folded about foldline 13 downwardly (FIGURE 3) and around the right-hand edges of panelsC, A and B as seen in FIGURE 4 to a position beneath main section B. Inaccordance with an important feature of the present invention the upperand lower edges of the package so formed are crimped as indicated atcrimp lines 24 and 25 of FIGURE 4.

To utilize the packaged suture 20, the package may be held as shown inFIGURE 5. The left hand 26 shown in FIGURE 5 may be that of a nursepresenting the package to the surgeon; and the right hand 28 may be thatof the surgeon removing the suture directly from the package 10 forimmediate use. The nurse may expose the needle by lifting the flapformed by panels C and D and the surgeon may then simply grasp theneedle 21 and pull to free the suture. As is set forth in our previousapplication the overall arrangement of the package and particularly thelinear zig-zag arrangement of the main portion of the suture permit thesuture to be removed rapidly and in a condition completely free fromtangles.

In accordance with our earlier filed application discussed above, theouter longitudinal edge of panel C would extend to a position short ofthe right-hand edge of the package formed along fold line 12, a positionindicated by dotted line C in FIGURE 3. The provision of overlapping endpanel D of the present invention serves a number of purposes. First, theoverlapping panel D provides a more secure enclosure for needle 21 inthat in the prior construction the upper flap formed by panel C wouldhave a tendency to open. Coupled with the endcrirnping provided by crimplines 24 and 25, overlapping panel D provides secure imprisonment ofneedle 21.

It will be appreciated that the package of the invention is easier tohandle than that of the prior construction in that the likelihood of thecovering flap formed by panel C coming open in handling with attendantspoilage of the sterilization of the needle 21 is greatly reduced.

A further important advantage of the overlapping panel D and crimping24, 25 will be discussed after consideration of FIGURE 6. FIGURE 6 showsan enlarged sectional view of the packaging material which is comprisedof a base or inner layer of absorbent material, an intermediate layer 31of metallic foil and an outer layer 32 of paper. Inner layer 30 isformed of absorbent material such as absorbent paper in order to retainthe alcohol or other liquid used in keeping the surgical gut moist.Intermediate layer 31 which may for example be constructed of aluminumfoil serves to provide a good liquid seal as well as to provide securecrimping of the ends of the package, the metallic foil taking a crimpbetter than ordinary paper. Outer layer 32 may have matter printedthereof such as identification markings and instructions as to use as isindicated in FIGURES 2 to 4.

The most important function of the three-layer material is to providemeans for absorbing the moistening liquid and for sealing the liquid inthe package. Regarding the sealing feature it will be appreciated thatthe snug closure of the package 10 provided by end panel of flap Dgreatly enhances the sealing effect of layer 31.

From the foregoing it can be seen that the configuration of the package,i.e., the multi-folded panel construction, the provision of the end flapD, the crimping of the edges of package, and the sealing provided byintermediate layer 31 all serve in retaining the surgical gut in a moistusable state. The absorbent sheathing provided by the absorbent layer 30increases the reservoir for the moistening liquid while the specificpackaging construction provides a sealed container for the liquidwhereby the evaporation rate of the liquid is decreased. The arrangementdisclosed further permits the package to be readily opened so that thegut can be removed quickly in an untangled state.

It is noted that in accordance with another important feature of theinvention the surgical gut of the suture may be presoaked until optimalconditioning is reached. This technique enables an equilibrium conditionto be reached and thus evaporation of the tubing fluid is combatted. Theamount of tubing fluid placed in the package to give optimalconditioning to the surgical gut is a definite quantity. This quantitymay be completely absorbed or almost completely absorbed particularlywhere an absorbent layer is included. With the inclusion of a pre-soakedabsorbent layer spillage of the tubing fluid is also combatted becausethere is substantially no free fluid in the package.

It should be understood that the panel arrangement shown and describedis only illustrative and, for example, panel A could be replaced by apanel extending outwardly of the upper edge section B and foldable tocover that section. Other arrangements could be utilized with somepossible loss in ready removability of the suture. For example, thesides of the package could also be crimped and the end flap Deliminated. Further, it might be possible to eliminate crimping wherethe section of packaging material was quite large by using tight foldsalong the outside margins of overlapping portions of the package to formthe container for the tubing liquid. A relatively tight seal may beachieved with this latter method where a layer of metallic foil is usedfor part of the package material. Other modifications will occur tothose skilled in the art.

Having thus described our invention in the manner required by the PatentStatutes, We wish it to be understood that the foregoing disclosure isillustrative rather than definitive.

We claim:

1. A package containing a suiture of the type requiring fluid forconditioning comprising a flexible Package material folded to form atleast a bottom layer and a cover layer, the suture being disposedbetween the bottom layer and the cover layer; an end flap formed on saidcover layer, said end flap being folded under said bottom layer to forma container for retaining moistening liquid adjacent the suture; and theupper and lower edges of said bottom and cover layers being crimpedtogether, said crimping being the only means for sealing said upper andlower edges to prevent the escape of said moistening liquid.

2. A package in accordance with claim 1 wherein said packaging materialis formed of a plurality of layers of material and comprises a layer ofabsorbent material for retaining moistening liquid adjacent the suture.

3. A package in accordance with claim 2 wherein said packaging materialfurther comprises a layer of metallic foil.

4. A package in accordance with claim 3 wherein said package materialfurther comprises an outer layer of paper capable of carrying printedmaterial.

5. A package in accordance with claim 1 wherein the suture has a needleattached thereto and wherein said package material is further folded toproduce a middle layer, the main portion of the suture being imprisonedbetween the middle layer and the bottom layer and the needle end of thesuture being disposed between the middle layer and the cover layer.

6. A package in accordance with claim 1 wherein the suture has a needleattached thereto and the main portion of the suture, except for theneedle, is disposed in a zig-zag pattern.

7. A package in accordance with claim 1 wherein the suture has a needleattached thereto and wherein said pack-age material is further foldedalong a longitudinal axis to produce a middle layer, the cover layer andthe end flap being produced by a longitudinal fold line parallel to saidfold producing said middle layer; the main portion of the suture beingimprisoned between the middle layer and the bottom layer and beingdisposed in a zigzag pattern on said bottom layer, the needle end of thesuture being disposed between the middle layer and the cover layer; thepackaging material itself being formed of a plurality of layers ofmaterial including a layer of metallic foil.

8. A package in accordance with claim 1 wherein the suture is pre-soakedbefore insertion into the package.

9. A package in accordance with claim 8 wherein the packaging materialincludes an inner layer of absorbent material which is pre-soaked withtubing fluid before the suture is inserted and the pack-age is closed.

10. A package containing a suture of the type requiring fluid forconditioning comprising a flexible package material folded to form atleast abottom layer and a cover layer, a suture laid out on said bottomlayer and disposed between said bottom layer and said cover layer, anend flap formed on said cover layer and folded under said bottom layerto form a container for retaining moistening fluid adjacent the suture,the upper and lower edges of said bottom layer and said cover layerbeing crimped together, said crimping being the only means for sealingsaid upper and lower edges to prevent escape of said moistening fluidand said packaging material being formed of a plurality of layers ofdifferent materials and comprising a layer of absorbent material forretaining moistening liquid adjacent the suture and a layer of metallicfoil material for aiding in forming said sealed container.

References Cited UNITED STATES PATENTS 2,069,335 2/1937 Salfisberg2293.5 X 2,402,981 7/1946 Beal et al 206--63.2 2,959,280 11/1960 Lloyd206--63.3 2,993,589 7/1961 Zoller et a1 206-63.3 3,332,550 7/1967 Sejman20663.2 3,357,550 12/1967 Holmes et al. 206-633 FOREIGN PATENTS 358,29710/1931 Great Britain. 453,345 9/ 1936 Great Britain.

MARTHA L. RICE, Primary Examiner US. Cl. X.R. 2293.5, 48, 62

